Inclusion criteria:

• Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or positive functional study
• Acceptable candidate for PTCA, stenting, and emergent CABG surgery
• Female patients of childbearing potential must have negative pregnancy test within 7 days before the procedure
• Patient or patient's legal representative informed of nature of study, agrees to its provisions and has provided written informed consent as approved by IRB of respective clinical site
• Patient agrees to return to same research facility for all required post-procedure follow-up visits
• Lesion must be single de novo in native coronary artery, > 14 mm and < 27 mm in length, have a stenosis of > 50% and < 100%
• Vessel has a thrombolysis in myocardial infarction flow 2 or greater and reference diameter > 2.25 mm and < 2.75 mm

Exclusion criteria:

• Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticlopidine, clopidogrel, cobalt, nickel, chromium, molybdenum, polymer coatings, or sensitivity to contrast media, which cannot be adequately pre-medicated
• History of allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
• Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or white blood cell count < 3,000 cells/mm³
• Serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure
• Evidence of acute MI within 72 hours of intended index procedure (defined as Q wave MI or non-Q wave MI having CK enzymes > 2X the upper laboratory normal with presence of CK-MB elevated above Institution's upper limit of normal).

Note: Patients with evidence or suspicion of acute MI must have CK and CK-MB labs drawn and results reviewed prior to enrollment

• Planned PCI of any vessel within 30 days pre or post-index procedure
• During index procedure, target lesion requires treatment with a device other than PTCA prior to stent placement
• History of stroke or TIA within prior 6 months
• Active peptic ulcer or upper GI bleeding within prior 6 months
• History of bleeding diathesis or coagulopathy or patient will refuse blood transfusions
• Concurrent medical condition with life expectancy of less than 12 months
• Any previous or planned treatment of target vessel with anti-restenotic therapies including but not limited to brachytherapy.
• Currently participating in an investigational drug or another device study that has not completed primary endpoint; clinically interferes with current study endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures
• Documented LVEF < 30% at most recent evaluation
• Inability to comply with protocol required medication regimen
• Target lesion located in native vessel distal to anastomosis with saphenous vein graft or LIMA/RIMA bypass with > 40% diameter stenosis anywhere within graft
• Previous stenting in target vessel
• Target vessel has other lesions with > 40% diameter stenosis based on visual estimate or on-line QCA
• Target vessel has evidence of thrombus
• Target vessel is excessively tortuous (two bends > 90º to reach target lesion)

• Target lesion has any of the following characteristics:

  1. Location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending, left circumflex, or right coronary artery
  2. Involves a side branch > 2.0 mm in diameter
  3. Is at or distal to a > 45º bend in the vessel
  4. Is severely calcified
  5. Involves a bifurcation
• Unprotected left main coronary artery disease (an obstruction greater than 50% in the left main coronary artery)